VGM Sends Letter to FDA Asking to Expedite the Approval of the Philips Respironics Alternative Sound Abatement Foam
on July 21, 2021
VGM recognizes the impact that the current shortage of CPAP/RAD machines is having on your business and the DME industry as a whole. Until Philips Respironics receives approval from the FDA (Food and Drug Administration) regarding:
1) the process that will be used to repair and replace devices impacted by the recall and
2) the use of an alternative sound abatement foam in their devices,
they cannot offer any new or replacement units for those impacted by the recall. In an effort to expedite the FDA’s approval process for the alternative foam, VGM has sent this letter to the FDA outlining the implications of the recall and subsequent product shortage.
- vgm government